The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

· 250°F/121°C, 30 minutes Gravity
· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 15 minutes Gravity
· 275°F/135°C, 3 minutes Dynamic Air Removal
· 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 3 minutes Gravity
· 270°F/132°C, 10 minutes Gravity
· 275°F/135°C, 3 minutes Dynamic Air Removal
· 275°F/135°C, 3 minutes Gravity
· 275°F/135°C, 10 minutes Gravity

Device Description

The VERIFY® STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY® STEAM Integrating Indicator is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer manufacturer's directions. Prior to the use of the processed items, the Integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

AI/ML Overview

The provided document details the acceptance criteria and the study that proves the VERIFY® STEAM Integrating Indicator device meets these criteria.

Here's the extracted information:

Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Study Result
BIER Vessel Testing	Pass result at Stated Value (SV) for each temperature claimed (23.0 min at 121°C, 2.0 min at 132 °C, 1.2 min at 135 °C) AND Fail result at 15% below SV for each temperature claimed AND Fail result at 1°C below SV for each temperature claimed	PASS
Simulated Use Testing in Claimed Sterilization Cycles	100% Pass result under pass conditions AND 100% Fail result under fail conditions	PASS
Dry Heat Testing	Fail result when exposed to 140°C dry heat for 30 min	PASS
Verification of integrator stated values at biological indicator growth-negative cycle conditions	Integrator does not reach endpoint before the biological indicator is inactivated	PASS
Offset/Bleeding	Integrator shall not bleed or offset	PASS

Sample size used for the test set and the data provenance
- Sample Size: The document states that testing was performed on "3 Lots" for the BIER Vessel Testing. Specific numbers of individual devices tested within each lot are not provided.
- Data Provenance: The study was conducted by STERIS Corporation for FDA submission. Details on the specific country of origin for the testing data are not explicitly stated, but the company is based in Mentor, Ohio, USA, and the documentation pertains to submissions to the U.S. FDA. The study appears to be prospective testing specifically for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the device is a chemical indicator for sterilization. The "ground truth" is established by the physical and chemical parameters of the sterilization cycles (time, temperature, steam presence) and the inactivation of biological indicators. It does not involve human expert interpretation in the way, for example, a diagnostic imaging device would.
Adjudication method for the test set
- This is not applicable for a chemical indicator. The endpoint is a visual change (migration of a dark bar into an "ACCEPT (OK)" window) determined by the chemical reaction to physical parameters, not human interpretation requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable to this device. The VERIFY® STEAM Integrating Indicator is a standalone chemical indicator, not an AI-powered diagnostic tool requiring human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, essentially. The performance testing described (BIER Vessel Testing, Simulated Use Testing, Dry Heat Testing, BI growth-negative cycle, Offset/Bleeding) evaluates the device's inherent physical and chemical behavior in response to sterilization conditions, independent of active human intervention during its function. Its output (pass/fail indication) is then read by a human.
The type of ground truth used
- The ground truth is based on the physical parameters of the steam sterilization cycles (time and temperature) and the inactivation of biological indicators (BIs). The device's chemical reaction indicates whether these critical parameters have been met sufficiently to achieve sterilization, which is then correlated with BI inactivation.
The sample size for the training set
- This information is not explicitly provided. Chemical indicators are typically characterized and validated, but the concept of a "training set" as understood in machine learning/AI is not directly applicable here. The device's performance is based on its physical design and chemical formulation, which would have been developed and refined through R&D (implicitly "trained" on various conditions) rather than a formal machine learning training set. The approval document focuses on validation/verification testing.
How the ground truth for the training set was established
- As noted above, the concept of a "training set" in the context of AI is not applicable. The device's "ground truth" for its development would have been established through extensive laboratory characterization of its chemical reaction kinetics under varying steam sterilization conditions (temperature, time, steam presence) to ensure it correlates accurately with microbial inactivation (sterilization). This would involve controlled experiments in BIER vessels and other sterilization equipment across a range of conditions, using established sterilization principles and biological indicators as the ultimate arbiters of sterilization effectiveness.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure, composed of three overlapping profiles, symbolizing health and well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 12, 2016

Steris Corporation Bill Brodbeck, Ph.D. Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K152630

Trade/Device Name: VERIFY® STEAM Integrating Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: Class II Product Code: JOJ Dated: April 11, 2016 Received: April 12, 2016

Dear Dr. Brodbeck:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152630

Device Name VERIFY® STEAM Integrating Indicator

Indications for Use (Describe)

Steam Sterilization Cycles:

· 250°F/121°C, 30 minutes Gravity
· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 15 minutes Gravity
· 275°F/135°C, 3 minutes Dynamic Air Removal
· 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 3 minutes Gravity
· 270°F/132°C, 10 minutes Gravity
· 275°F/135°C, 3 minutes Dynamic Air Removal
· 275°F/135°C, 3 minutes Gravity
· 275°F/135°C, 10 minutes Gravity

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with a registered trademark symbol to the right. Below the word is an image of several horizontal, wavy lines in a light blue color, resembling water waves.

510(k) Summary for VERIFY® STEAM Integrating Indicator

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459

Manufacturing Facility

Dana Products, Inc. 11457 Melrose Street Franklin Park, IL 60131

Contact:

Bill Brodbeck, Ph.D. Director, Regulatory Affairs Telephone: (440) 392-7690 (440) 357-9198 Fax No: e-mail: William brodbeck(@steris.com

May 12, 2016 Submission Date:

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

{5}------------------------------------------------

1. Device Name

Trade Name:	VERIFY® STEAM Integrating Indicator
Device Classification:	Class II
Common/usual Name:	Indicator, physical/chemical sterilization process
Classification Name:	Indicator, physical/chemical sterilization process(21 CFR 880.2800, JOJ)

2. Predicate Device

Dana Steam Sterilization Integrator (K012195), Dana Products Inc.

3. Description of Device

4. Intended Use

The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

· 250°F/121°C, 30 minutes Gravity
· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 15 minutes Gravity
· 275°F/135°C, 3 minutes dynamic air removal
· 275°F/135°C, 10 minutes Gravity

{6}------------------------------------------------

Steam Sterilization Cvcles (IUSS):

· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 3 minutes Gravity
· 270°F/132°C, 10 minutes Gravity
· 275°F/135°C, 3 minutes dynamic air removal
· 275°F/135°C, 3 minutes Gravity
· 275°F/135°C, 10 minutes Gravity

ડ. Description of Safety and Substantial Equivalence

The proposed and predicate devices are single use integrating indicators for use in monitoring steam sterilization cycles. The products are identical in design with the exception of the labeling, which is being revised as a result of rebranding the device under the VERIFY product family (STERIS purchased Dana Products Inc. in March, 2015). The differences between the proposed VERIFY® |STEAM Integrating Indicator and the predicate Dana Steam Sterilization Integrator are limited to expanding the indications for use statement to include use of the device to monitor various steam sterilization cycles. These differences do not raise any new issues of safety and efficacy. Performance testing has been conducted for monitoring all claimed steam sterilization cycles in accordance with the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators.

6. Technological Characteristics

The proposed and predicate devices are single use integrating indicators for use in monitoring particular steam sterilization cycles. The device components, mechanism of action, and endpoint are the same as the predicate's and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible migration of the included chemistry to indicate that stated values have been achieved.

Table 5-1 contains a comparison of technological characteristics and specifications of the proposed VERIFY® STEAM Integrating Indicator to the predicate Dana Steam Sterilization Integrator.

{7}------------------------------------------------

	Proposed	K012195	Comparison
Feature	VERIFY® STEAMIntegrating Indicator	Dana Steam SterilizationIntegrator
Intended use	The integrating indicator isdesigned to chemically reactover time with the criticalparameters of steamsterilization cycle within aspecified tolerance. Theintegrating indicator strip isintended to be placed in eachpack, pouch, container, tray orother containment device tofunction as an independentmonitor of critical parametersfor the following sterilizationcycles:Steam Sterilization Cycles:•250°F/121°C, 30 minutesGravity•270°F/132°C, 4 minutesDynamic Air Removal•270°F/132°C, 15 minutesGravity•275°F/135°C, 3 minutesdynamic air removal•275°F/135°C, 10 minutesGravitySteam Sterilization Cycles(IUSS):•270°F/132°C, 4 minutesDynamic Air Removal•270°F/132°C, 3 minutesGravity•270°F/132°C, 10 minutesGravity•275°F/135°C, 3 minutesdynamic air removal•275°F/135°C, 3 minutesGravity•275°F/135°C, 10 minutesGravity	Dana Steam SterilizationIntegrators are intended to beused to monitor criticalparameters in steamsterilization cycles inhealthcare facilities. Thecritical parameters for whichthe integrators will respondare time and temperature(when steam is present). Theend point is determined by themigration of the steamsensitive dye to an areamarked safe on the indicator.The integrators are intended tobe used in 30 minute gravitycycles at 250 degrees F and 3minute gravity and pre-vacuum cycles at 270 degreesF.	The intended usestatement has beenupdated to reflectspecific uses of thesubject device aswell expand theindicated cycles toinclude thosecommonly utilizedin healthcarefacilities. Testing inconformance withthe Guidance forIndustry and FDAStaff: PremarketNotification[510(k)]Submissions forChemical Indicatorsfor integratingindicators addressesany concernsregarding the safetyand efficacy of theproposed device inregards to theclaimed steamsterilization cycles.

Table 5-1. Device Comparison Table

{8}------------------------------------------------

16 Interactive Review

VERIFY® STEAM Integrating Indicator

	Proposed	K012195	Comparison
Feature	VERIFY® STEAM	Dana Steam Sterilization
	Integrating Indicator	Integrator
Devicedesign -components	Backing material withembossed cavity containingtemperature sensitive chemicaland coloring dye, wicking strip,covered with laminated papercontaining labeling andwindows.	Backing material withembossed cavity containingtemperature sensitive chemicaland coloring dye, wicking strip,covered with laminated papercontaining labeling andwindows.	Device design andcomponents areidentical withexception of theprinted labeling.
Indicatoragent	Proprietary formulation	Proprietary formulation	The indicator agentis identical to thepredicate.
Sterilizationmethod andcycles	Per intended use above.	30 minute gravity cycles at250 degrees F and 3 minutegravity and pre-vacuum cyclesat 270 degrees F.	The intended cyclesvary betweenindicators. Intendedcycles for theproposed device willbe verified andvalidated inaccordance with theGuidance forIndustry and FDAStaff: PremarketNotification[510(k)]Submissions forChemical Indicators.
Mechanismof action	Proprietary	Proprietary	Mechanism ofaction is identical topredicate.
Endpointspecifications	The end point is determinedby the migration of the steamsensitive dye to an areamarked ACCEPT (OK) on theindicator. Endpoint is reachedat the stated value (SV) foreach claimed temperature.Endpoint is not reached at thestated value - 15% time and/or-1°C.	The end point is determinedby the migration of the steamsensitive dye to an areamarked safe on the indicator.Endpoint is reached at thestated value (SV) for eachclaimed temperature. Endpointis not reached at the statedvalue - 15% time and/or -1°C.	The end point is thesame for proposedand predicatedevices.
Feature	ProposedVERIFY® STEAMIntegrating Indicator	K012195Dana Steam SterilizationIntegrator	Comparison
Comparisonof integratorstated valuesat biologicalindicatorgrowth-negativecycleconditions	Integrator does not reachendpoint before the biologicalindicator is inactivated.	Integrator does not reachendpoint before the biologicalindicator is inactivated	Same performanceobserved.
Shelf-life	5 years	5 years	Proposed andpredicate deviceshave the identicaldesign and thereforecarry the same shelf-life claims.
Standard /Guidance	Conforms to the Guidance forIndustry and FDA Staff:Premarket Notification[510(k)] Submissions forChemical Indicators forintegrating indicators andANSI/AAMI/ISO 11140-1:2014: Sterilization of HealthCare Products - ChemicalIndicators - Part 1: GeneralRequirements.	Conforms to ST60:Sterilization of Health CareProducts - Chemical Indicators- Part 1: GeneralRequirements.	Both proposed andpredicate devicesmeet the applicablestandards at the timeof their introductioninto interstatecommerce.

{9}------------------------------------------------

K152630 Response to 5/12/16 Interactive Review VERIFY® STEAM Integrating Indicator

7. Performance Testing

Performance testing was conducted to verify that the proposed VERIFY® STEAM Integrating Indicator meets the requirements for integrating indicators in accordance with the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140-1:2014.

Table 5-2 summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the proposed VERIFY® STEAM Integrating Indicator is as safe and is as effective. These studies confirm that the proposed device's performance meets the requirements of its predefined acceptance criteria and intended uses, and qualify the proposed device for use in the claimed steam sterilization cycles.

{10}------------------------------------------------

Stated Values

The subject device (integrator indicator) testing was performed in a bier vessel using the following stated values shown below at the following temperatures (see Table 5-2). The integrator indicator showed a passing result when the chemicals in the subject device reacted to all critical parameters in the bier vessel.

Test of 3 Lots	Acceptance Criteria	Study Result
BIER Vessel Testing	Pass result at SV for each temperature claimedStated values are:• 23.0 min at 121°C• 2.0 min at 132 °C• 1.2 min at 135 °CFail result at 15% below SV for eachtemperature claimedFail result at 1°C below SV for eachtemperature claimed	PASS
Simulated Use Testing inClaimed SterilizationCycles	100% Pass result under pass conditions100% Fail result under fail conditions	PASS
Dry Heat Testing	Fail result when exposed to 140°C dry heatfor 30 min	PASS
Verification of integratorstated values at biologicalindicator growth-negativecycle conditions	Integrator does not reach endpoint before thebiological indicator is inactivated	PASS
Offset/ Bleeding	Integrator shall not bleed or offset	PASS

Table 5-2. Verification Results Summary

The results of the VERIFY® STEAM Integrating Indicator performance testing demonstrate that both perform as intended in the claimed steam sterilization cycles and the proposed device is substantially equivalent to the predicate device.

8. Conclusion

The proposed device design is identical to that of predicate device, with the exception of the relabeling under the VERIFY brand. The intended use of the proposed device adds additional cycles and clarification of use conditions. The VERIFY® STEAM Integrating Indicator is as safe and is as effective when used to monitor the claimed steam sterilization cycles and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).